Durvalumab plus tremelimumab in patients with grade 3 neuroendocrine neoplasms of gastroenteropancreatic origin: Updated results from the multicenter phase II DUNE trial (GETNE 1601)

Abstract

Background.Previously reported treatment efficacy with durvalumab (D) plus tremelimumab (T) showed limited activity in patients (pts) with well differentiated neuroendocrine tumors (NETs). However, primary endpoint was achieved in grade 3 (G3) neuroendocrine neoplasms (NENs) suggesting a promising overall survival rate in a pretreated population. Here we update the results of the G3 cohort with central pathological review.Methods.DUNE was a prospective open-label trial that recruited pts with advanced NENs after progression to standard therapies in four cohorts (C1-4): typical/atypical lung carcinoids (C1), G1/2 gastrointestinal (C2), G1/2 pancreatic (C3), and G3 NENs of gastroenteropancreatic origin after progression to first-line platinum-based chemotherapy (C4). Pts received 1500 mg durvalumab (D) (up to 13 cycles) plus 75 mg tremelimumab (T)(up to 4 cycles) once every 4 weeks. Primary objective for C4 was the 9 months (m) overall survival rate (OS) expected to be over 23%.